Shoulder Pain Clinical Trial
Official title:
Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Verified date | December 2023 |
Source | MetroHealth Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).
Status | Active, not recruiting |
Enrollment | 116 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Shoulder pain of >3 months 2. Age>=21 3. Worst pain in the last week>=4 (0-10 scale) 4. Ability to check skin and perform dressing changes, independently or with assistance 5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic) Exclusion Criteria: 1. Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics 2. Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome) 3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.) 4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks 5. Uncontrolled bleeding disorder 6. Medical instability based on physician opinion after review of medical information 7. Pregnancy 8. Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.) 9. Current Worker's compensation claim for the ipsilateral shoulder 10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination 11. Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by another person)) 12. Current osseus fracture in ipsilateral arm 13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full) 14. Surgical indication for shoulder treatment based on physician opinion 15. Compromised immune system (immunodeficiency or immunosuppression) 16. Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System 17. Patients who have a tape or adhesive allergy 18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only |
Country | Name | City | State |
---|---|---|---|
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Univerity of Texas Southwestern | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
MetroHealth Medical Center | University of Texas |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Occurrence of Adverse events | Related adverse events are documented as Safety data. | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | |
Primary | Change in - Short Form (SF) question 3 (BPI-SF3) | The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." | Prior 7-days] ; Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | |
Secondary | Change in Brief Pain Inventory (BPI)- Short Form (SF) | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The question asks participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." ." In addition, the question asks the participant to rate how their pain interferes with daily activities where "0" indicates "does not interfere and "10" indicates "completely interferes". | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | |
Secondary | Change in Activities of Daily Living(ADL( capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) | The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a laboratory based objective measure of ADL capacity. The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a timed test that provides a brief measure of functional ability of the upper limb while performing multi-level tasks that require grip/manipulation of the hand, elbow/shoulder reaching, sustained overhead work, and sustained positioning with an emphasis on assessing the limitations in functional capacity attributable to shoulder and neck disorders | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | |
Secondary | Change in Activities of Daily Living (ADL) performance -Shoulder Pain and Disability Index (SPADI) | The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.The question asks severity of pain based on an 0-10 numerical Rating Scale where 0 = no pain and 10 = the worst pain imaginable. In addition, it asks how much difficulty the participant has on a numerical rating scale where 0 = no difficulty and 10 = so difficult it requires help. Total disability score: _____/ 80 x 100 = % Total SPADI score: _____ 130 x 100 = % Minimum Detectable Change (90% confidence) = 13 points (Change less than this may be attributable to measurement error). lower score is better. | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | |
Secondary | Change in Quality of life - Short form - 12(QoL - SF 12) | Quality of life - Short form - 12 (QoL - SF 12) is a health related Quality of life (QoL) measure that assesses physical functioning, role limitation because of physical health problems, bodily pain, social functioning, general mental health, role.
Scoring: Two summary scores are a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Lower score is better. |
Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment | |
Secondary | Change Mechanical Quantitative Sensory Testing (QST) | used to evaluate central sensitization | Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment |
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